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Ledipasvir/sofosbuvir for treatment-naive and treatment-experienced Chinese patients with genotype 1 HCV: an

Lai Wei1, Qing Xie2, Jin Lin Hou3

  • 1Beijing Key Lab for Hepatitis C and Immunologic Liver Disease, Peking University Hepatology Institute, Peking University People's Hospital, 11 Xizhimen S St, Xicheng District, Beijing, 100044, China. weilai@pkuph.edu.cn.

Hepatology International
|April 12, 2018
PubMed

Insights

Ledipasvir/sofosbuvir achieved a 100% sustained virologic response rate in Chinese patients with genotype 1 hepatitis C virus (HCV) infection. This highly effective treatment was well-tolerated, regardless of prior treatment or cirrhosis status.

Area of Science:

  • Hepatology and Viral Gastroenterology
  • Infectious Diseases
  • Pharmacology and Therapeutics

Background:

  • Chronic hepatitis C virus (HCV) infection poses a significant health burden in China, impacting over 10 million individuals.
  • Ledipasvir/sofosbuvir has demonstrated high sustained virologic response (SVR) rates in clinical trials and real-world settings for genotype 1 HCV.
  • This single-tablet regimen offers a potentially effective and short-duration treatment option for Chinese HCV patients.

Purpose of the Study:

  • To evaluate the efficacy and safety of ledipasvir/sofosbuvir in Chinese patients with genotype 1 HCV.
  • To assess SVR12 rates in treatment-naive and treatment-experienced patients, including those with compensated cirrhosis.
  • To determine the impact of baseline resistance-associated substitutions (RASs) on treatment outcomes.

Main Methods:

  • An open-label study treated 206 Chinese patients (treatment-naive or experienced, with or without compensated cirrhosis) with ledipasvir/sofosbuvir for 12 weeks.
  • The primary efficacy endpoint was sustained virologic response 12 weeks post-treatment (SVR12).
  • Safety was assessed by adverse events leading to discontinuation and serious adverse events; viral sequencing evaluated RASs.

Main Results:

  • All 206 patients achieved SVR12 (100%), significantly superior to the historical SVR rate of 57% for treatment-naive patients (p < 0.001).
  • Patients with baseline NS5A and NS5B RASs also achieved SVR12.
  • The treatment was well-tolerated, with no discontinuations or serious adverse events related to the study drug. Common adverse events included upper respiratory tract infections and cough.

Conclusions:

  • Ledipasvir/sofosbuvir is a highly effective and well-tolerated treatment for Chinese patients with genotype 1 HCV.
  • Treatment efficacy is maintained regardless of prior treatment experience, cirrhosis status, or the presence of pretreatment RASs.
  • This regimen represents a valuable therapeutic option for managing HCV in the Chinese population.
Abstract

Keywords:
ChinaGenotype 1Hepatitis C virusLedipasvirSingle-tablet regimenSofosbuvir

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